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Model Number MSM20 |
Device Problems
Failure to Advance (2524); Failure to Form Staple (2579); Failure to Fire (2610)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # t94t2l.Investigation summary: the analysis results found that the msm20 device was returned with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, it was noted that the clips did not advance into the jaw.In addition, the feeder shoe was noted to be stuck in home position, not allowing the clip to advance into the jaws.The device was disassembled in order to evaluate the condition of the internal components and the feeder spring was noted to be in opposite position.Eight clips were found inside clip track.The damage to the device has been correlated to the manufacturing process.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.
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Event Description
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It was reported that during an unknown procedure, the clips were not engaging.The yellow 'pusher' was not moving clips to end as required/ expected.Originally, the device did not feed the clips.The clips would move if applier was turned upside down.However, then clips misfired.In some instances, they would not fire at all, in others they were malformed and would not clip properly.The device was not fired over another clip or hard structure.Discontinued use of this affected item and another product was opened; thus no delay to patient's surgery.The affected product did not cause harm to patient.
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Search Alerts/Recalls
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